BEUDAMED
    FDA Recall Terminated

    Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003; Softrace Neonatal Wire Attached, Catalog Number: 2321-003; Softrace Pediatric Wire Attached, Catalog Number: 2331-003; Softrace Limb Band, Catalog Number: 2310-003; TRU-LINK ECG Electrode (Neonatal Pre-Wired), Catalog Number: 685-0037-00; for use with electrocardiographic monitoring equipment to detect neonatal/pediatric heart action voltages.

    Recall: Z-1493-2011 · Initiated September 23, 2010

    Recall

    Recall Number
    Z-1493-2011
    Event Number
    57827
    Firm
    ConMed Corporation
    FEI Number
    3001451571
    Product Code
    DRX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 23, 2010
    Posted
    March 2, 2011
    Terminated
    October 28, 2014
    Address
    525 French Road, Utica, NY, 13502

    Description

    Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003; Softrace Neonatal Wire Attached, Catalog Number: 2321-003; Softrace Pediatric Wire Attached, Catalog Number: 2331-003; Softrace Limb Band, Catalog Number: 2310-003; TRU-LINK ECG Electrode (Neonatal Pre-Wired), Catalog Number: 685-0037-00; for use with electrocardiographic monitoring equipment to detect neonatal/pediatric heart action voltages.

    Reason

    Poor signal or loss of signal. Certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality.

    Action

    ConMed Corporation distributed an Urgent Device Recall notification letter on Tru-Link ECG Electrode (Neonatal Pre-wired) dated September 23, 2010. ConMed Corp. has advised to cease the use of the devices immediately and conducted a recall to the user level. Direct consignees were asked to contact sub-accounts if recalled devices were further distributed and notified them of such recall. Recalled devices were to return to ConMed Corp. at 525 French Road, Utica, NY 13502 with completed Attachment II to indicate the amount returned. Customers with no recalled devices were asked to fill out Attachment II and faxed to 315-624-3225. Questions can be directed to Ms. Patricia Cotter, ConMed Recall Coordinator at 315-624-3237 or fax to 315-624-3225 or email to [email protected].

    Distribution

    Worldwide distribution, including USA, Dubai, Ecuador, Egypt, Germany, Holland, Indonesia, Israel, Italy, Jamaica, Kenya, Korea, Lithuania, Malaysia, Mexico, New Zealand, Norway, Qatar, Saudi Arabia, Singapore, South Africa, Sweden, Switzerland, US Virgin Islands, Canada and Belgium.

    Quantity

    9,009,000 Pediatric/Neonatal ECG Electrodes with Attached Wire